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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K231861
Device Name EndoflipTM 300 System
Applicant
Covidien, LLC
3062 Bunkerhill Ln.
Santa Clara,  CA  95054
Applicant Contact Viviana Gonzalez
Correspondent
Covidien, LLC
3062 Bunkerhill Ln.
Santa Clara,  CA  95054
Correspondent Contact Viviana Gonzalez
Regulation Number876.1725
Classification Product Code
FFX  
Date Received06/23/2023
Decision Date 07/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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